Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)
|ClinicalTrials.gov Identifier: NCT01465464|
Recruitment Status : Terminated
First Posted : November 4, 2011
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Orantinib (TSU-68) Drug: Placebo||Phase 3|
This is a randomized, multi-center, double-blind, placebo-controlled phase III trial of Orantinib administered in combination with TACE in patients with unresectable HCC.
Patients will be randomly assigned (1:1) to receive TACE given in combination with either Orantinib (200 mg orally, twice per day) or placebo.
ORIENTAL:ORantinib InvEstigatioN on TAce combination triaL.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||888 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||November 2014|
Drug: Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
|Placebo Comparator: Placebo||
1 tablet was administered orally twice per day after meals, morning and evening.
- Overall Survival(OS) [ Time Frame: The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient ]
- Time to Transcatheter Arterial Chemoembolization (TACE) Failure [ Time Frame: The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient ]
Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.
- The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE
- Deterioration in arterial pathways to treat HCC that makes additional TACE impossible
- Severe vascular invasion occurs that makes additional TACE impossible
- Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC
- Liver function at grade Child-Pugh class C lasting for 28 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465464
|Osaka-sayama, Osaka, Japan, 589-8511|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Chiba, Japan, 260-8677|
|Korea, Republic of|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Seoul, Korea, Republic of, 110-744|
|Taipei, Taiwan, 100|
|Study Director:||Taiho Pharmaceutical Co., Ltd.||Taiho Pharmaceutical Co., Ltd.|